New Drug Approval Regulatory Services India

India is a country which has a drug regulatory system operating at the Central Level as well as the State Level. At Central level, Central Drugs Standards Control Organization (CDSCO) is the organization which has been given the prime responsibility of approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

On 19th March, 2019 vide G.S.R. 227 (E), India has published new set of regulations which are applicable for all types of new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee. These rules are known as New Drugs and Clinical Trial Rules, 2019.

We help our clients in strategizing, formulation development, dossier preparation, filing and resolving queries. We help our clients understand the requirements of the drug approval process, so that there is no ambiguity or confusion in the process to follow. This makes their new drug approval experience stress free. Transparency and accountability are basic principles imbibed in the team handling new drugs approval.

a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labeling thereof and has not been approved as safe and efficacious by the Central Licensing Authority with respect to its claims; or
a drug approved by the Central Licensing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or
a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or
a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licensing Authority; or
a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal antibodyanti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug;

Explanation: The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licensing Authority and the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new drugs.

India has a federal structure where there is a power sharing between the central authorities and the state authorities. Even in the drug approval process there are different stages where you need approval from Central authorities and at certain stages approval from state authorities are desired.

At API First, we solve this puzzle for you. We provide a clear pathway for our Indian manufacturers, Overseas manufacturers as well as importers so that the complete drug approval becomes hassle free and expedited. We strategize, prepare dossiers and file applications. We follow-up the applications till their approvals.

API First is a team of regulatory experts who are well versed with the nuances of the regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. The team of experts have a vast experience with the drug approval process in India.